Researchers call for more women in clinical trials

Published: 3-Apr-2007
Regulatory

European Union researchers have warned that systemic exclusions of women from pharmaceutical clinical trials could pose health risks, because some diseases affect women differently from men.


European Union researchers have warned that systemic exclusions of women from pharmaceutical clinical trials could pose health risks, because some diseases affect women differently from men.

University of Amsterdam scientists leading an EU-funded project found no research ethics committees in five EU member states had formal requirements to include a gender expert.

'An evaluation of equitable inclusion of women and men in studies is required neither in regulations nor in tools supporting ethical assessment procedures,' a report concluded. 'This is also true for gender-specific analysis of risks and benefits associated with study participation.'

A related European Commission note cited the heart drug digoxin where trials were carried out on 80% male groups. Later studies showed women taking digoxin died earlier than placebo patients, a problem undetected in original tests.

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